510(k) K801619
K801619 is an FDA 510(k) premarket notification submitted by Mistogen Equipment Co. for the device "MIST2GEN TEMPTROL 10". The FDA issued a decision of Substantially Equivalent on August 4, 1980. The device falls under product code BTT (Humidifier, Respiratory Gas, (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5450. Mistogen Equipment Co. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1980
- Date Received
- July 15, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Respiratory Gas, (Direct Patient Interface)
- Device Class
- Class II
- Regulation Number
- 868.5450
- Review Panel
- AN
- Submission Type